Sermonix Pharmaceuticals LLC, a specialty pharmaceutical company focused on the development and commercialization of emerging late-stage women’s health products, announced today that experts in sexual medicine will give two presentations related to its investigational drug, lasofoxifene, at the annual meeting of the International Society for the Study of Women’s Sexual Health (ISSWSH) on February 26 and 27.
The meeting in Charleston, South Carolina, will include two presentations on lasofoxifene:
- Stanley Althof, Ph.D, Executive Director, Center for Marital and Sexual Health of South Florida; and Sheryl Kingsberg, Ph.D, Division Chief, Ob/Gyn Behavioral Medicine at University Hospitals Case Medical Center, authored “A Phase 2 proof of concept program on Female Sexual Arousal Disorder and Hypoactive Sexual Desire Disorder: Patient Characteristics and Implications for Diagnosis and Treatment of Female Sexual Dysfunction”
- Michael Krychman, M.D., Executive Director of the Southern California Center for Sexual Health and Survivorship Medicine, will present “Correlation of Physiologic Markers of Vulvovaginal Atrophy and Symptom Severity in Postmenopausal Women With Genitourinary Syndrome of Menopause”
“I’m looking forward to sharing information from this important study with my colleagues,” Dr. Kingsberg said of her presentation. “There remain many unanswered questions about the metrics used to study female sexual dysfunctions (FSDs). The lasofoxifene Phase 2 program provides a wealth of information on women suffering with FSDs and gives insight that improves our understanding of how to effectively treat women’s sexual concerns.”
Lasofoxifene, evaluated in over 15,000 women in a comprehensive worldwide Phase I-III clinical development program that includes the PEARL, OPAL and GARNET trials, is an investigational selective estrogen receptor modulator (SERM). It is unique in that it has demonstrated reduction in both vertebral and non-vertebral fractures in postmenopausal osteoporosis, improvement of symptoms of vulvovaginal atrophy (VVA), also known as genitourinary syndrome of menopause (GSM), and an 83 percent decrease in the incidence of ER+ breast cancer patients followed out to five years.
“Lasofoxifene’s Phase 3 VVA studies demonstrated statistical and clinically significant improvement in key primary endpoints,” Dr. Krychman said. “We are also looking at some exciting potential biomarkers for symptom severity in our present analysis.”
Sermonix is a sponsor of the ISSWSH annual meeting.
“We’re thrilled to support the patients, clinicians and researchers that the Society serves,” said David Portman, M.D., chief executive officer and chief medical officer of Sermonix. “We hope the meeting, as well as our accepted presentations, continue to help advance the understanding of women’s menopausal and sexual health concerns.”
More on lasofoxifene
Lasofoxifene — a SERM, also known as an estrogen agonist/antagonist — was originally developed through a collaboration between Ligand Pharmaceuticals and Pfizer. Pfizer developed lasofoxifene for osteoporosis. It did not receive FDA clearance in 2009; however, in Europe lasofoxifene was approved for osteoporosis treatment by the EMEA that same year. Pfizer never marketed lasofoxifene in Europe and subsequently rights to lasofoxifene reverted back to Ligand in 2011. Sermonix obtained licensing rights to lasofoxifene from Ligand in February 2015 and is currently seeking regulatory approval.
Sermonix Pharmaceuticals LLC is a specialty pharmaceutical company focused on bringing new and emerging late-stage women’s health products through clinical development and regulatory approval. Founded in 2014, Sermonix has assembled considerable talent within women’s healthcare clinical development and product commercialization. Dr. David Portman, Sermonix’s founder and CEO, was principal investigator for the Phase II and Phase III lasofoxifene clinical trials and was actively involved during the drug’s clinical development. Dr. Portman has experience in all stages of the regulatory approval process. James Symons, MS, PhD, is Vice President of Clinical Development at Sermonix and was the global clinical lead for the lasofoxifene development program for vulvovaginal atrophy as well as for multiple women’s health submissions to the FDA during his tenure at Pfizer. Elizabeth Attias, MMSc, ScD, Vice President of Business Development has experience in all stages of women’s health product assessment, market development, launch and commercialization.